Devices in the German Hospital Sector Oliver Martini Director - - PowerPoint PPT Presentation

Market Access Pathways for Medical Devices in the German Hospital Sector

Oliver Martini

Director Government Affairs & Policy Germany Medical Devices, Pharmaceuticals and Consumer

Funding Pathways for Medical Devices

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Medical Devices Inhospital Ambulatory

• III. Day-surgery at

the hospital

• II. Department with
• ext. physiscians
• I. Main department
• IV. Ambulatory

Sevices AOP-contract acc. to 115b SGB V Fee for Service (EBM) DRG ZE Fee for Service (EBM) DRG ZE Fee for Service (EBM) Heilmittel

Reimbursement Scheme

Reimbursement Check-up for Innovations

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New Technology = new Method Costs covered by DRG? Regular Care

 



NUB? Outcome > Standard?





OPS Procedure Code? Potential acc. §137c(3) SGB V?

Outcome > Standard? Costs > Standard? NUB? Regular Care

 

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Market Access for Hospital Innovations

Standard process

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NUB- Application Hospital NUB- Status 1 €€€€ Negotiation

Potential of relevant treatment alternative acc. 137c (3) SGB V

• New Diagnostic or Treament Method?
• Clinical & economic relevance?

Method is covered by DRG adequate?

• Cost difference > fiirst standard diviation of DRG costs?

New Process for Disruptive Innovations with High Risk Medical Devices with very Invasive Character

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First time NUB Application High Risk Medical Device with very Invasive Character (MPhR) Disruptive Innovative Method with new theoretical-scientific concept

Regulated by MeMBV Medical Device Method Evaluation Regulation

Market Access for Disruptive Innovation

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HTA Dossier submitted by hospital Statements & Dossier

Method with new scientific- theoretical Concept?

&

Benefit Assessment

&

2 weeks 1 month 3 month

NUB- Application Hosptial NUB- Status 1 €€€€ Negotiation

• First-time NUB Application?
• MP Risk class IIa / III & very invasive character?
• Aignment with Manufacturer

Potential acc. 137c (3) SGB V

Benefit Assessement of the Innovation

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Measure Assess Decide

G-BA Code of Procedure (Verfahrensordnung) G-BA Decision A

Full Evidence Accepted

B

No RCTs, but Potential for an Alternative Treatment Option

A

Negative evidence, harmful

CED Rapid HTA by

• Method paper 4.2
• Pharma approach
• Only RCT accepted

Challanges of Innovation Payment Clause

• acc. to § 137e/h social code book V
• Early Benefit Assessment of Inpatient Methods

– Early dialogue on relevance of new method too late and insufficient – Decision on potential  high evidence threshold  comparative trial – Missing SOP for reassessment, if a method was excluded from DRG based on missing potential benefit – Missing SOP for evidence generation  uncertainty in planning and calculation

• Coverage with evidence development directive according to §137e SGB V

– Duration of procedures on determination of the CED decision and the CED study  high risk for comparative advantage in terms of innovation and profitability – High cost  uncertainty and missing compensation options – Uncertain reimbursement  risk of lower ROI than expected

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Announced Changes of the nnovation Payment Clause acc. to §137h SGB V through Medical Appointment Service and Care Law (TSVG)

• Early dialogue with Joint Federal Committee (G-BA)
• NUB application of the hospital needs “agreement” instead “consultation” with

the medical device manufacturer (MDM)

• No proof of “potential” as treatment alternative by G-BA / IQWiG / no

comparative trials needed at NUB application

• G-BA will sponsor all Coverage with Evidence Development (CED) trials

unless the medical device manufacturer (MDM) will sponsor it (fast track)

• Fast Track for CED trial, as company sponsored CED trial commissioned by

an independent institution / institute listed by the FJC

• Ambulatory care: Payback of investment by the MDM after access to the

remuneration system for ambulatory care

Supports BVMed members & forces the political discussion

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Question?

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Oliver Martini Director Government Affairs & Policy Germany Medical Devices, Pharmaceuticals and Consumer

Charlottenstraße 59 ││ D - 10117 Berlin Cell: +49 - 173 54 55 932

• martini@its.jnj.com

http://www.jnj.com